GB/T 37875-2019 PDF English
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GB/T 37875-2019: Technical specification for quality evaluation of nucleic acid extraction and purification kits
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(Nucleic acid extraction and purification kit quality evaluation technical specification) ICS 07.080 G00 National Standards of People's Republic of China Nucleic acid extraction and purification kit Quality evaluation technical specification Technicalspecificationforqualityevaluationofnucleic Acidextractionandpurificationkits Published on.2019-08-30 2019-08-30 implementation State market supervision and administration China National Standardization Administration issued Content Foreword I 1 Scope 1 2 Normative references 1 3 Terms and definitions, abbreviations 1 3.1 Terms and Definitions 1 3.2 Abbreviations 2 4 Evaluation Indicator 3 4.1 Production 3 4.2 Purity 3 4.3 Completeness 3 4.4 Repeatability 3 4.5 Reproducibility 3 4.6 Inter-batch variation 3 4.7 Bacterial endotoxin residues 3 5 Evaluation method 3 5.1 General 3 5.2 Production 3 5.3 Purity 3 5.4 Integrity 4 5.5 Repeatability 4 5.6 Reproducibility 4 5.7 Inter-batch differences 4 5.8 Bacterial endotoxin residues 5 6 Quality Evaluation Report 5 Appendix A (informative) Determination of nucleic acid extraction yield, purity, integrity and bacterial endotoxin residues 6
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and managed by the National Standards Research Center. This standard was drafted. China Institute of Metrology, Beijing Kangwei Century Biotechnology Co., Ltd. The main drafters of this standard. Fu Boqiang, Wang Jing, Duan Jiali, Wang Chunxiang, Chen Minwei, Tang Zhiyu, Niu Chunyan, Dong Lianhua, Gao Yunhua. Nucleic acid extraction and purification kit Quality evaluation technical specification1 Scope
This standard specifies the terms and definitions of quality evaluation of nucleic acid extraction and purification kits, technical indicators for quality evaluation and evaluation methods. This standard applies to the production and service of DNA and RNA extraction and purification kits for bacteria, plasmids, eukaryotic cells, etc.2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 20001.4-2015 Standard Writing Rules Part 4. Test Method Standards JJF1001-2011 General Measurement Terms and Definitions JJF1265-2010 Biometric Terms and Definitions 3 terms and definitions, abbreviations 3.1 Terms and definitions The following terms and definitions defined in GB/T 20001.4-2015, JJF1001-2011 and JJF1265-2010 apply to this paper. Pieces. For ease of use, the following lists one of GB/T 20001.4-2015, JJF1001-2011 and JJF1265-2010. These terms and definitions. 3.1.1 Nucleic acid primary structure nucleicacidprimarystructure The order of nucleotides (or base order) in a polynucleotide chain. 3.1.2 Reference material referencematerial A substance with a sufficiently uniform and stable specific characteristic whose characteristics have been proven to be suitable for use in measurement or in the investigation of nominal characteristics use. [JJF1001-2011, definition 8.14] 3.1.3 Precision precision The degree of agreement between the independent test/measurement results obtained under specified conditions. Note 1. Precision depends only on the distribution of random errors, independent of true or specified values. Note 2. The measure of precision is usually expressed in terms of “not precise”, and its value is expressed by the standard deviation of the test result or measurement result. Standard deviation Large, the lower the precision. Note 3. The quantitative measure of precision is strictly dependent on the specified conditions, and the repetitive conditions and reproducibility conditions are two extreme cases. [GB/T 20001.4-2015, definition 3.3] GB/T 37875-2019 (Nucleic acid extraction and purification kit quality evaluation technical specification) ICS 07.080 G00 National Standards of People's Republic of China Nucleic acid extraction and purification kit Quality evaluation technical specification Technicalspecificationforqualityevaluationofnucleic Acidextractionandpurificationkits Published on.2019-08-30 2019-08-30 implementation State market supervision and administration China National Standardization Administration issued Content Foreword I 1 Scope 1 2 Normative references 1 3 Terms and definitions, abbreviations 1 3.1 Terms and Definitions 1 3.2 Abbreviations 2 4 Evaluation Indicator 3 4.1 Production 3 4.2 Purity 3 4.3 Completeness 3 4.4 Repeatability 3 4.5 Reproducibility 3 4.6 Inter-batch variation 3 4.7 Bacterial endotoxin residues 3 5 Evaluation method 3 5.1 General 3 5.2 Production 3 5.3 Purity 3 5.4 Integrity 4 5.5 Repeatability 4 5.6 Reproducibility 4 5.7 Inter-batch differences 4 5.8 Bacterial endotoxin residues 5 6 Quality Evaluation Report 5 Appendix A (informative) Determination of nucleic acid extraction yield, purity, integrity and bacterial endotoxin residues 6Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and managed by the National Standards Research Center. This standard was drafted. China Institute of Metrology, Beijing Kangwei Century Biotechnology Co., Ltd. The main drafters of this standard. Fu Boqiang, Wang Jing, Duan Jiali, Wang Chunxiang, Chen Minwei, Tang Zhiyu, Niu Chunyan, Dong Lianhua, Gao Yunhua. Nucleic acid extraction and purification kit Quality evaluation technical specification1 Scope
This standard specifies the terms and definitions of quality evaluation of nucleic acid extraction and purification kits, technical indicators for quality evaluation and evaluation methods. This standard applies to the production and service of DNA and RNA extraction and purification kits for bacteria, plasmids, eukaryotic cells, etc.2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 20001.4-2015 Standard Writing Rules Part 4. Test Method Standards JJF1001-2011 General Measurement Terms and Definitions JJF1265-2010 Biometric Terms and Definitions 3 terms and definitions, abbreviations 3.1 Terms and definitions The following terms and definitions defined in GB/T 20001.4-2015, JJF1001-2011 and JJF1265-2010 apply to this paper. Pieces. For ease of use, the following lists one of GB/T 20001.4-2015, JJF1001-2011 and JJF1265-2010. These terms and definitions. 3.1.1 Nucleic acid primary structure nucleicacidprimarystructure The order of nucleotides (or base order) in a polynucleotide chain. 3.1.2 Reference material referencematerial A substance with a sufficiently uniform and stable specific characteristic whose characteristics have been proven to be suitable for use in measurement or in the investigation of nominal characteristics use. [JJF1001-2011, definition 8.14] 3.1.3 Precision precision The degree of agreement between the independent test/measurement results obtained under specified conditions. Note 1. Precision depends only on the distribution of random errors, independent of true or specified values. Note 2. The measure of precision is usually expressed in terms of “not precise”, and its value is expressed by the standard deviation of the test result or measurement result. Standard deviation Large, the lower the precision. Note 3. The quantitative measure of precision is strictly dependent on the specified conditions, and the repetitive conditions and reproducibility conditions are two extreme cases. [GB/T 20001.4-2015, definition 3.3] ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
